In the NOHARM trial, a strategy to promote nondrug pain management after surgery reduced exposure to opioids without worsening pain interference, physical function, and other patient-reported outcomes.

“Electronic health record (EHR)–enabled strategies that emphasize patient-centered decision-making and education may reduce opioid exposure while maintaining patient-centered outcomes, reinforcing the ongoing need for patient education to address opioid-related harms,” said Andrea Cheville, co–principal investigator for NOHARM and a professor of physical medicine and rehabilitation at Mayo Clinic.

The results of the study were published online in JAMA Network Open.

Pain after surgery is often treated with opioid medications, which for some patients can lead to prolonged opioid use, impaired recovery, and postoperative complications. Clinical guidelines recommend incorporating nondrug approaches into postoperative pain management, but barriers to their routine use have hindered widespread adoption of these strategies.

The NOHARM study team, led by Cheville and co–principal investigator Jon Tilburt, conducted a cluster randomized trial in 6 high-volume surgical centers in Arizona, Florida, Minnesota, and Wisconsin. The EHR-based intervention included an educational guide for patients about nondrug pain care modalities, clinical decision support prompting clinicians to reinforce patients’ nondrug pain care choices, and a collection of educational and self-management resources. The components of the intervention were delivered at multiple points along the perioperative care continuum.

“Partnering with allied health staff, including nurses, physical therapists, and occupational therapists, allowed us to systematically connect patients with nonpharmacologic pain management resources while formalizing processes that could be scaled across practices and sites,” said Tilburt, a professor of medicine at Mayo Clinic.

In the study’s stepped-wedge design, clusters of surgical procedures defined by surgical department and site were randomly assigned to 1 of 5 sequences. At 7-month intervals, the sequences began with a 6-month usual care period and crossed over to the intervention. A total of 68,141 surgical procedures were included in the analysis, of which 25,088 were performed during the usual care period and 43,053 were performed during the intervention period.

The researchers found no change in patient-reported pain interference and physical function. However, the intervention reduced exposure to opioids after surgery, including administration of opioids in the hospital and prescription of opioids at discharge. These reductions in opioid exposure were achieved without worsening patient-reported outcomes, opioid-related adverse events, or other safety outcomes.

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“Pragmatic trials in large healthcare systems often feel like a sprint during implementation, requiring navigation of stakeholder buy-in, operational challenges, and EHR integration,” Cheville said. “The NIH Collaboratory’s ongoing support throughout the clinical trial provided our team with a trusted sounding board for addressing unanticipated challenges and informing key decisions.”

NOHARM is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant award from the National Institute of Neurological Disorders and Stroke administered by the National Institute on Aging. Learn more about NOHARM.